Curonix LLCJune 24, 2022

FDA 483 - Curonix LLC - June 24, 2022

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Record Details

Stimwave Technologies, Incorporated, a medical device manufacturer in Pompano Beach, FL, was cited for three significant quality system deficiencies during an FDA inspection. The observations included inadequate corrective and preventive action procedures, particularly concerning a patient shock complaint, and issues with process control for product release. Additionally, the firm failed to adequately establish requirements for supplier evaluation.

Company: Curonix LLC
Inspection Date: June 24, 2022
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
People: Ebony D. Sanon
Stanley B. Eugene (investigator)

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ID · dc6449e0-b46e-4e76-9814-b4a8eadfc16e